Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)

Ocular Hypertension Clinical Trial

— SAF-24H-IOP  

Official title:

Comparative Evaluation of Intraocular Pressure During the 24 Hour in Patients Affected by Primary Open-angle Glaucoma and Ocular Hypertension: Latanoprost 0.005% Versus Tafluprost 0.0015% Ophthalmic Solutions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162603
• Other study ID #: AOBS-SAF-01
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2010
• Last updated: May 5, 2013
• Start date: March 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeItaly: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

• Main objective is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.

• Secondary objectives will be the comparison between Latanoprost 0.005% and Tafluprost 0.0015% ophthalmic solution about:

• Mean 24-hour IOP values after three months of treatment

• IOP values at these time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients > 45 years

• Damage of the optic nerve and alterations of the visual field in case of POAG, no defects at the optic nerve and at the visual field in case of OHT

• Untreated IOP > 24 mm Hg but < 32 mm Hg in at least one eye at baseline (10AM) and central corneal thickness between 500 and 600 µm

• Negative pregnancy test (fertile women). Fertile women attending the study must express clear will to avoid pregnancy during all the study period and in the next three months

• Informed consent before starting the study

Exclusion Criteria:

• Secondary glaucoma (Sturge-Weber syndrome, Neurofibromatosis I, neovascular glaucoma, steroid glaucoma, etc)

• Anterior segment anomalies (cataract, irido-corneal disgenesy, congenital ectropion uvae, etc)

• Past ocular surgery, except cataract surgery in the previous 6 months

• Corneal abnormalities that can influence IOP measurements (corneal oedema)

• Positive pregnancy test or breast-feeding woman. No will to avoid pregnancy during all the study period and in the next three months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Device:
• Goldmann and Perkins applanation tonometry
IOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment

Drug:
• TAFLUPROST 0.0015% EYEDROPS
Tafluprost 0.0015% preservative-free ophthalmic solution
• LATANOPROST 0.005% EYEDROPS
Latanoprost 0.005% preservative-added ophthalmic solution

Locations

Country	Name	City	State
Greece	Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital	Thessaloniki
Italy	USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia	Aristotle University Of Thessaloniki

Countries where clinical trial is conducted

Greece,  Italy, 

References & Publications (4)

Aihara M. Clinical appraisal of tafluprost in the reduction of elevated intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. Clin Ophthalmol. 2010 Mar 24;4:163-70. — View Citation

Hommer A, Mohammed Ramez O, Burchert M, Kimmich F. IOP-lowering efficacy and tolerability of preservative-free tafluprost 0.0015% among patients with ocular hypertension or glaucoma. Curr Med Res Opin. 2010 Aug;26(8):1905-13. doi: 10.1185/03007995.2010.49 — View Citation

Kuwayama Y, Komemushi S; Tafluprost Multi-center Study Group. [Intraocular pressure lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal tension glaucoma: randomized, double-blind, multicenter, phase III study]. Nippon Ganka Gakkai Zasshi. 2010 May;114(5):436-43. Japanese. — View Citation

Uusitalo H, Pillunat LE, Ropo A; Phase III Study Investigators. Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study. Acta Ophthalmol. 2010 Feb;88(1):12-9. doi: 10.1111/j.1755-3768.2010.01862.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	Primary endpoint of this crossover trial is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.	24-hour	No